MacroGenics Gets Nod For Margenza In HER2-Positive Breast Cancer
Company Reaches Milestone With First FDA Approval
The drug may see a muted launch given the competitive landscape and a broad label despite its efficacy advantage in F-allele patients.
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Top-line results from the Phase III TULIP study show that Byondis’s next-generation antibody-drug conjugate, trastuzumab duocarmazine (SYD985) is superior to physicians' choice of therapy for delaying disease progression in patients with advanced HER2-positive breast cancer.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
MacroGenics' BLA for full approval in the US is under way and the company already has established a manufacturing facility in preparation for a launch.